Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy

• ClinicalTrials.gov Identifier: NCT00888654
• Recruitment Status: Completed
• First Posted: April 27, 2009
• Results First Posted: March 30, 2015
• Last Update Posted: March 19, 2018
• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Elisabeth Heath, Barbara Ann Karmanos Cancer Institute

Study Description

Brief Summary:

RATIONALE: The use of diindolylmethane, a substance found in cruciferous vegetables, may slow the growth of tumor cells.

PURPOSE: This phase II trial is studying how well diindolylmethane works in treating patients with stage I or stage II prostate cancer undergoing radical prostatectomy.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: B-Dim; Procedure: Radical Prosatectomy	Phase 2

Detailed Description:

OBJECTIVES:

Primary

• To measure the level of diindolylmethane in prostate tissue after treatment with oral microencapsulated diindolylmethane (B-DIM) in patients with stage I or II adenocarcinoma of the prostate undergoing radical prostatectomy.

Secondary

• To measure serum biomarkers (e.g., total PSA, serum testosterone, and diindolylmethane levels) pre- and post-treatment with B-DIM.
• To measure tissue biomarkers (e.g., androgen receptor, NF-κB, and PSA) pre- and post-treatment with B-DIM.

OUTLINE: This is a multicenter study.

Patients receive oral microencapsulated diindolylmethane (B-DIM) twice daily for 14-72 days in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy 1 day after the last dose of B-DIM.

Patients undergo blood and tissue sample collection for correlative laboratory studies. Blood samples are analyzed for serum PSA, testosterone, and diindolylmethane levels by high performance liquid chromatography and tandem mass spectrometry (LC-MS/MS). Tissue samples are analyzed for diindolylmethane concentration by LC-MS/MS and for androgen receptor, activated NF-κB (p65 antibody), and PSA expression by IHC.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
• Study Start Date: August 2009
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: B-Dim, Radical Prosatectomy; B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy	Drug: B-Dim; B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery); Other Name: 3,3'-Diindolylmethane; Procedure: Radical Prosatectomy; Other Name: therapeutic conventional surgery

Outcome Measures

Primary Outcome Measures :

1. Mean Level of Diindolylmethane in Prostate Tissue After Treatment [ Time Frame: Within the first 24 months after radical prostatectomy. ]

Secondary Outcome Measures :

1. Serum Levels of PSA, Testosterone, and Diindolylmethane [ Time Frame: Pre and post radical prostatectomy ]
   Serum levels of PSA, testosterone, and diindolylmethane (DIM)
2. Levels of Androgen Receptor in Prostate Tissue [ Time Frame: Pre and post radical prostatectomy ]
   Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

  • Stage I or II (T1-T2 a, b, or c) disease
  • Disease confined to the prostate by clinical judgment of the surgeon
• Deemed an appropriate candidate for surgery by clinical judgment of the surgeon

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and/or ALT ≤ 2.5 times ULN if alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN if AST and/or ALT normal
• Serum creatinine ≤ 2.0 mg/dL
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to oral microencapsulated diindolylmethane

• No concurrent uncontrolled illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive hart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, hormonal therapy, brachytherapy, cryotherapy, external beam radiotherapy, or other therapy for prostate cancer
• No concurrent micronutrient supplements or dietary soy products
• No concurrent systemic therapy for any other cancer
• No concurrent p450 inducers or inhibitors (e.g., carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, or rifampin)
• No concurrent finasteride or dutasteride
• No other concurrent investigational or commercial agents or therapies for the malignancy

Contacts and Locations

Locations

United States, Michigan

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201-1379

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Elisabeth I. Heath, MD; Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database 

• Responsible Party: Elisabeth Heath, Principal Investigator, Barbara Ann Karmanos Cancer Institute
• ClinicalTrials.gov Identifier: NCT00888654
• Other Study ID Numbers: CDR0000641168; P30CA022453 ( U.S. NIH Grant/Contract ); WSU-2007-128
• First Posted: April 27, 2009
• Results First Posted: March 30, 2015
• Last Update Posted: March 19, 2018
• Last Verified: November 2017

Keywords provided by Elisabeth Heath, Barbara Ann Karmanos Cancer Institute:

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; 3,3'-diindolylmethane; Anticarcinogenic Agents; Protective Agents; Physiological Effects of Drugs; Antineoplastic Agents